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Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)

This study has been withdrawn prior to enrollment.
(No longer viable)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00541320
First received: February 12, 2007
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.


Condition Intervention Phase
Venous Thromboembolism
 Drug: GW813893
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery. [ Time Frame: symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery. ]

Secondary Outcome Measures:
  • Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery. [ Time Frame: Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery ]

Enrollment: 0
Study Start Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients who are scheduled for primary elective unilateral total knee arthroplasty.

Exclusion criteria:

  • Women who are not surgically sterile or post-menopausal
  • Have a contra-indication to contract venography
  • Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541320

Locations
United States, Alabama
GSK Clinical Trials Call Center
Birmingham, Alabama, United States, 35209
United States, Arizona
GSK Clinical Trials Call Center
Phoenix, Arizona, United States, 85023
GSK Clinical Trials Call Center`
Phoenix, Arizona, United States, 85023
United States, California
GSK Clinical Trials Call Center
Yuba City, California, United States, 95991
United States, Florida
GSK Clinical Trials Call Center
St. Petersburg, Florida, United States, 33703
United States, Georgia
GSK Clinical Trials Call Center
Decatur, Georgia, United States, 30032
United States, South Carolina
GSK Clinical Trials Call Center
Charleston, South Carolina, United States, 29414
United States, Texas
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00541320     History of Changes
Other Study ID Numbers: FTI102595
Study First Received: February 12, 2007
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Anti-thrombolytic direct Factor Xa inhibitor

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on June 18, 2013